Aortic Valve Replacement Versus Conservative Treatment in Asymptomatic Severe Aortic Stenosis

• Register: ClinicalTrials.gov
• Last refreshed on: 17 May 2021
• Main ID: NCT02436655
• Date of registration: 30/04/2015
• Prospective Registration: Yes
• Primary sponsor: Clinical Centre of Serbia
• Public title: Aortic Valve Replacement Versus Conservative Treatment in Asymptomatic Severe Aortic Stenosis AVATAR
• Scientific title: Aortic Valve Replacement Versus Conservative Treatment in Asymptomatic Severe Aortic Stenosis: (AVATAR Trial): A Multicentre Randomized Controlled Trial
• Date of first enrolment: June 2015
• Target sample size: 157
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02436655
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Belgium, Croatia, Czech Republic, Czechia, France, Ireland, Italy, Lithuania, Poland, Serbia, Spain

Contacts

• Name: Svetozar Putnik, MD, PhD
• Affiliation: Cardiac Surgery Department, University Clinical Centre of Serbia

• Name: Marko Banovic, MD, PhD, FESC, FACC
• Affiliation: Cardiology Department, University Clinical Centre of Serbia

Key inclusion & exclusion criteria

Inclusion Criteria:

- men and women of any ethnic origin aged =18 years

- Written informed consent

- V max across the aortic valve > 4m/s or Pmean = 40mmHg and AVA = 1cm2 or AVAi =
0.6cm2/m2 at rest

- Without reported symptoms

- Society of Thoracic Surgeons (STS) score < 8%

Exclusion Criteria:

- Participation in another clinical trial within 30 days prior randomization

- Pregnant or nursing women

- Mental condition rendering the patient unable to understand the nature, scope and
possible consequences of the study or to follow the protocol

- Positive stress-test defined as:

1. Anginal chest pain during testing

2. Syncope, dizziness during testing

3. Decrease in systolic blood pressure during exercise = 20mmHg

4. Malignant arrhythmia during exercise testing (VT or VF)

- Left ventricular ejection fraction < 50% at rest

- Very severe AS (defined as Vmax > 5.5 m/s at rest)

- Significant disease of other valves (Mitral stenosis with Pmean > 5mg, or any
significant regurgitation = 3+

- Recent AMI (< 1 year)

- Need for additional by-pass surgery or for aortic root replacement (i.e Bentall) or
ascending aorta in asymptomatic patients undergoing AVR

- Previous by-pass surgery

- Previous any heart valve surgery

- Impaired renal function, i.e. creatinine >200 µmol/L or glomerular filtration rate <
30 mL/min/1.73 m2

- Significant pulmonary hypertension at rest (PASP > 50mmHg)

- Uncontrolled hypertension at rest (systolic >180 mmHg and diastolic >100 mmHg)

- Significant co-morbidity with reduced life expectance (< 3 years)

- Uncontrolled Diabetes Mellitus (HbA1C > 9 %)

- Significant COPD (FEV1 < 70% of predicted value)

- Permanent or paroxysmal atrial fibrillation



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Aortic Stenosis

Intervention(s)

Procedure: surgical aortic valve replacement

Primary Outcome(s)

all cause death, Major Adverse Cardiac Event (MACE) including: ( Acute Myocardial Infarction - AMI, Stroke - CVI, unplanned hospitalization for Heart failure (HF) needing intravenous treatment [Time Frame: 36 months]

Secondary Outcome(s)

major bleeding according to consensus report from the Bleeding Academic Research Consortium [Time Frame: 1 year]

repeat aortic valve surgery in operated patients in both groups [Time Frame: 1 year]

in-hospital and 30 days operative mortality in operated patients in both groups [Time Frame: 30 days]

repeated major adverse cardiovascular events [Time Frame: 1 year]

thromboembolic complications based on clinical symptoms, signs and imaging studies [Time Frame: 1 year]

Secondary ID(s)

FWA00011929

Source(s) of Monetary Support

Please refer to primary and secondary sponsors